1.Recognized quality management system Based on Chinese GMP, 21CFR part 210, 211, EU cGMP Volume 4 and ICH Guidelines, ThinHeal has established a quality management system encompassing the product lifecycle, providing comprehensive quality assurance for the products.
2. Effective project managements With abundant experience of multiple projects managements, ThinHeal can ensure the smooth and effective implementation of the projects per customer’s requirements.
3. cGMP experiences With extensive cGMP management experiences, ThinHeal can undertake the product transfer, process validation, and commercial manufacturing according to the cGMP requirements of different countries (including China, the United States, the European Union, and Japan).
4. Cost effective managements，Cost is always considered by ThinHeal during the peptide synthesis route selection, purification process optimization and the quality control. ThinHeal helps our customers improve the product quality with cost effective and efficient solutions.
5. Platform for process development
API: up to 40 amino acids synthesis experience, including but not limited to the synthesis of linear peptide/cyclic peptide/multiple disulfide bonds; solid phase/liquid phase peptide synthesis & assembly coupling; peptide modification & Multi cyclic peptide synthesis.
Finished Products: including injection, oral controlled release preparation, long-term peptide injection process development and quality control, scale-up and stability study experience.
6. More than 20 years experience for regulatory application and registration in both dosmetic and overseas.